On December 18, 2012 Ad-Tech Medical Instrument Corporation initiated a recall of 115 Macro Micro Subdural Electrodes. There is a concern the microelectrodes are not flush with the silastic surface. As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity.
Recalled Product(s) were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.
The following Macro Micro Subdural Electrodes have been recalled:
CATALOG NUMBERS
|
LOT NUMBER
|
BATCH
NUMBER |
QTY
|
QGC8A-SP10N-OOO
|
G608060002
|
0020161
|
1
|
QGC8D-SP10N-OOO
|
C704040001
|
0025418
|
1
|
QGC8A-SP10N-OOO
|
G704150001
|
0026119
|
1
|
QGC8A-SP10N-OOO
|
C703160006
|
0026358
|
2
|
EGE4A-SP10N-OOO
|
C702201001
|
0029304
|
1
|
QGC8A-SP10N-OOO
|
C805210003
|
0030815
|
1
|
QG36A-SP10N-000
|
C805210004
|
0030819
|
2
|
QG36A-SP10N-OOO
|
C802220003
|
0031061
|
1
|
QGC8A-SP10N-OOO
|
C802220005
|
0031035
|
1
|
EGE4A-SP10N-OOO
|
C802220006
|
0031104
0031094 |
2
|
EGE4A-SP10N-OOO
|
C801240003
|
0032308
|
2
|
EGE4A-SP10N-OOO
|
C800250002
|
0033276
|
1
|
EGE4A-SP10N-OOO
|
C800350004
|
0033277
|
1
|
EGE4A-SP10N-OOO
|
G805270001
|
0034692
|
1
|
QGC8B-SP10X-OOO
|
208140314
|
0038610
|
1
|
EGE4A-SP10X-OOO
|
208140314
|
0038520
0038521 0038522 |
3
|
QGC8A-SP10N-OOO
|
G903080003
|
0041526
|
1
|
QG36A-SP10N-OOO
|
5903080004
|
0041659
|
1
|
QS20A-SP10N-OOO
|
5905280003
|
0042295
|
1
|
QGC8C-SP10X-OOO
|
208140343
|
0043004
|
1
|
QGC8B-SP10X-OOO
|
208140344
|
0043076
|
1
|
EGD7A-MP12N-OOO
|
G903011001
|
0043905
|
1
|
EGD7A-MP12N-OOO
|
G900211002
|
0044215
|
1
|
QG18A-SP10N-OOO
|
C908221002
|
0044840
|
2
|
QG16A-SP10X-OOO
|
208140353
|
0044772
|
2
|
QG18A-SP10X-OOO
|
208140353
|
0044835
|
2
|
QGC8B-SP10X-OOO
|
208140354
|
0044932
|
1
|
QGC8A-SP10N-OOO
|
G015020002
|
0045573
|
1
|
QG20B-SP10N-OOO
|
019020
|
0045227
|
3
|
QG53A-SP10X-OOO
|
208140362
|
0046112
|
1
|
QG96A-SP10N-OOO
|
G012140002
|
0047160
|
1
|
QG66A-SP85N-OOO
|
G016240001
|
0047248
|
1
|
QG96A-SP10X-OOO
|
208140369
|
0047159
|
1
|
QGC8D-SP10N-OOO
|
G019150003
|
0048115
|
1
|
QG26A-SP10N-OOO
|
G017250004
|
0048221
|
1
|
QG36B-SP10N-OOO
|
G0172S0005
|
0048224
|
1
|
EG10A-SP10N-OOO
|
G017250006
|
0048181
|
1
|
QG96A-SP10X-OOO
|
208140374
|
0047724
|
1
|
EG34B-SP10X-OOO
|
208140381
|
0048753
|
1
|
QG20E-SP10X-OOO
|
208140382
|
0048898
|
1
|
QG20D-SP10X-200
|
208140382
|
0048899
|
1
|
QGC8E-SP10X-OOO
|
208140382
|
0048901
|
1
|
QG36A-SP10N-OOO
|
C010180001
|
0050030
|
2
|
QG36A-SP10X-OOO
|
208140387
|
0050031
|
2
|
QG17A-SP10X-OOO
|
208140390
|
0050218
|
1
|
QG18A-SP10X-OOO
|
208140395
|
0051090
|
2
|
QG20F-SP10X-OOO
|
208140398
|
0051181
|
1
|
QG10B-SP10X-OOO
|
208140398
|
0051442
|
1
|
QG18A-SP10N-OOO
|
G012111001
|
0051906
|
1
|
QG18A-SP10N-OOO
|
G018011001
|
0051663
|
1
|
QG10C-SP10N-OOO
|
G018011003
|
0051667
|
2
|
QG10D-SP10N-OOO
|
G018011002
|
0051675
|
2
|
QG11A-SP10X-OOO
|
208140399
|
0051598
|
2
|
QG10C-SP10N-OOO
|
G019021002
|
0052519
|
2
|
QG10D-SP10N-OOO
|
G019021003
|
0052260
|
2
|
QGC8B-SP10X-OOO
|
208140356R
|
0044932
|
1
|
QGC6A-SP07N-OOO
|
G119020004
|
0053503
|
1
|
QG20B-SP10X-OOO
|
208140357R
|
0045319
|
1
|
QG16A-SP10X-OOO
|
208140414
|
0054443
|
3
|
QG16A-SP10X-OOO
|
208140417
|
0055275
|
1
|
QGC8F-SP10X-OOO
|
208140421
|
0055934
|
1
|
QG36A-SP10N-OOO
|
G114160002
|
0056510
|
1
|
QG10C-SP10N-OOO
|
G114160001
|
0056441
|
1
|
QG36A-SP10N-OOO
|
G115170004
|
0057159
|
1
|
QG20C-SP10N-OOO
|
G112270004
|
0057110
|
2
|
QG96C-SP10X-OOO
|
208140431
|
0057422
|
1
|
QS40B-SP10X-OOO
|
208140431
|
0057284
|
1
|
QG36A-SP10N-OOO
|
G115080002
|
0057839
|
1
|
QG24A-SP10N-OOO
|
G115280005
|
0058246
|
2
|
QG20B-SP10X-OOO
|
208140357R
|
0045319
|
1
|
QG20B-SP10X-OOO
|
208140357R
|
0045319
|
1
|
QG20C-SP10X-OOO
|
208140443
|
0059392
|
1
|
QGC8A-SP10X-OOO
|
208140443
|
0059234
|
1
|
QG18A-SP10X-OOO
|
208140443
|
0059248
|
1
|
QG11A-SP10X-OOO
|
208140445
|
0059777
|
1
|
QG32A-SP10X-OOO
|
208140450
|
0060750
|
1
|
QG32B-SP10X-OOO
|
208140450
|
0060751
|
2
|
QG96C-SP10X-OOO
|
208140450
|
0060500
|
1
|
QG96D-SP10X-OOO
|
208140450
|
0060740
|
2
|
QG16A-SP10X-OOO
|
208140452
|
0060830
0060878 |
2
|
QG18A-SP10X-OOO
|
208140452
|
0060879
|
2
|
QG88A-SP10X-OOO
|
208140452R
|
0060885
|
1
|
QG44A-SP10X-OOO
|
208140453
|
0061307
|
2
|
QG69A-SP10N-OOO
|
G211220001
|
0062673
|
1
|
QG36A-SP10X-OOO
|
208140450
|
0059620
|
2
|
QG36A-SP10X-OOO
|
208140458
|
0061050
|
1
|
Product(s) can be identified by the label provided on the packaging.
Ad-Tech Medical Instrument Corporation voluntarily recalled the Macro Micro Subdural Electrodes after becoming aware of potential harm to the patient. Ad-Tech Medical Instrument Corporation has notified the FDA of this action.
There has been one reported serious injury that may have been related to the use of the device.
http://www.fda.gov/Safety/Recalls/ucm341680.htm
